Getting Started
Step 0: If you aren’t sure if your research activity requires IRB Review, check these resources:
- What needs IRB Review Video [HTML]
- What needs IRB Review Guide [PDF]
- Research vs. Quality Improvement [HTML Interactive Tool]
Additional information is available on the "What Needs IRB Review" webpage. [HTML]
If you’re still not sure or you need an official determination, complete the ORI Not Human Research (NHR) Form. [HTML]
Step 1: Complete your Human Subject Protection (HSP) training [HTML] and other applicable training required by UK (e.g., annual Responsible Conduct in Research (RCR) training).
Ensure all study personnel on the IRB application have current HSP training. You can submit the IRB application before training is completed, however completion is a condition of IRB approval. You can view training status in the columns labeled “HSP” and “HSP Date” in the Study Personnel section of your IRB application.
Study personnel without current HSP training may be removed until they complete the training, at which time you may submit a modification request (MR) [HTML] to add them back to the study personnel list.
Resources
- Human Subject Protection (HSP) Frequently Asked Questions (FAQs) [HTML]
- UK CITI Access [HTML]
- "Study Personnel – UK and Non-UK – Adding and Removing" E-IRB video tutorial [HTML]
- Adding Non-UK Study Personnel [D163.0000] [PDF]
- Responsible Conduct of Research & Scholarly Activity (RCR) [HTML]
- Sponsor/Investigator training (GCP) FAQs [HTML]
Step 2: Open the New Researcher Frequently Asked Questions (FAQs) interactive tool [HTML] as you begin the process. The FAQs provide fundamental information such as which review type and whether you should submit to the medical or nonmedical IRB. If you’re new to the UK Institutional Review Board (IRB) process, watch ORI’s brief IRB overview video. [HTML]
Useful Links to Bookmark as you complete your IRB application
- Research Terms Dictionary [HTML Interactive Tool]
- Acronyms list [PDF]
- IRB FAQs [HTML]
Step 3: Determine the applicable IRB review type. [HTML]
Exempt Review
Categories of minimal risk research reviewed by one IRB member
- Exemption Category Table Tool [PDF]
- Exempt Review Decision [HTML Interactive Tool]
- Exemption Decision Charts [PDF]
Expedited Review
Broad categories of minimal risk research reviewed by one IRB member and consultants if needed
- Issues to be addressed [PDF];
Full Convened IRB Review
Research that is greater than minimal risk or doesn’t fit in exempt or expedited categories.
Step 4: Complete the IRB submission in E-IRB. [HTML]
Before starting your application, watch the brief IRB Submission Tips video. [HTML] New investigators, student researchers, or studies with complex protocols or vulnerable populations are invited to request a consult with ORI staff for guidance. [REDCap Form]
Use the applicable checklist to help you navigate the application:
E-IRB System Resources
- ABC’s of E-IRB Video Tutorial Series
- Create Application Video Tutorials
- Attachment Management Video Tutorials
- Change Principal Investigator (PI) Video Tutorial
- E-IRB FAQs [HTML Interactive Tool]
- IRB Review Types webpage [HTML]
Step 5: Identify protocol-specific requirements to address in the application, including:
Subject Population
- Determine who the study population includes. This includes interaction, intervention with people or their private identifiable information or material.
- Estimate the demographics of the subject population. Consider using these tools:
- Consider safeguards for vulnerable populations, including:
- Economically or Educationally Disadvantaged [PDF]
- Impaired Consent Capacity Policy [PDF]
- UK IRB Policy on Children in Research [PDF]
- Guidance for Enrolling University Students as Research Subjects [PDF]
- Guidance for Enrolling K-12 Students as Research Subjects [PDF]
- Student Record Research - Family Educational Rights and Privacy Act (FERPA) [PDF]
- Student Survey Research - U.S. Department of Education/Protection of Pupil Rights Amendment (PPRA) [PDF]
- Research Involving Prisoners [HTML]
- Research Involving Pregnant Women, Fetuses, and/or Neonates [HTML]
Research-Specific Requirements
See the relevant heading in the IRB Survival Handbook [HTML], if any of the following requirements or issues apply to your study:
- Certificate of Confidentiality
- Clinical Trials
- Conflicts of Interest
- Data Security
- Deception
- Digital Technology and Internet Research
- Data & Safety Monitoring
- Disclose and manage Conflict of Interest
- Deception Research
- Future Use and Secondary Research
- Funding Agency Requirements
- Genetic or Genomic Data (Repositories, Tissue Banks, Registries)
- HIPAA in Research
- International Research
- Recruitment
- Suicidality in Research
- Survey Research
Research-Site-Specific or IRB Reliance (Multi-Site, Collaborative)
If your research involves collaboration with any sites and/or personnel outside the University of Kentucky, IRB Reliance or other off-site permission issues may need to be addressed. (This may include national multi-center trials as well local studies involving sites/personnel external to UK.)
Contact IRBReliance@uky.edu early in the planning process so we can help you determine the type of coverage that is appropriate for your project.
Other Human Research Review Committees
Biosafety, Radiation Safety, Markey Cancer Center, etc. [HTML]
Step 6: Determine informed consent needs and check at least one of the items in the Informed Consent Section of the application.
Obtaining Informed Consent/Assent
- Consent/assent templates are available in E-IRB and on the informed consent webpage [HTML]
- The Informed Consent Development link includes lay term glossaries, resources to improve readability, Key Information examples and more [HTML]
- See Sample Key Information for examples of information to present first in the document and process [HTML]
- Attach consent/assent files – See the tutorial on how to attach for approval stamps and replace attachments [HTML]
- Use the Informed Consent Requirement Checklist to ensure documents have all items required by federal regulations and local policies [PDF]
- ORI Remote Informed Consent Guidance [PDF]
Waiving Informed Consent/Assent or Signatures
- Waiver of Consent vs Waiver of Consent Signatures [HTML]
Step 7: Obtain required signatures, then complete the submission section to submit your application to the Office of Research Integrity.
Upon completion of the application, send the application to designated signees. Once they have signed, the PI will sign the application. After all signatures have been obtained, send the application to ORI.
Once your application has been submitted, you can find a view only version in your Submitted folder under your PI Dashboard.
Obtaining Required Signatures/Submit Application
- Video tutorial on how to obtain signatures [Signatures (Assurances) Section - How to Complete]
- Faculty Advisor signature/responsibilities [HTML]
- Department Chair signature/responsibilities [PDF]
What happens after IRB approval?
Conduct the Research
- Upon receipt of the IRB Approval letter, download "A Principal Investigator's Guide to Responsibilities, Qualifications, Records and Documentation of Human Subjects Research" [PDF] and conduct your study in compliance to ethical and regulatory requirements.
- Download the one page quick guide for what you need to report to the IRB during the study, such as unanticipated problems or protocol violations [PDF]
- Obtaining IRB approval before modifying or deviating from your approved application [HTML]
- The IRB can only approve Expedited and Full review research for one year. ORI will remind you prior to the date approval expires, so that you can submit an annual report to prevent your approval from expiring. Download a sample Annual Administrative Review (AAR) for Expedited protocols or Continuing Review (CR) form for Full protocols, so you know the information to collect while conducting research. [HTML]
- Access the UK Electronic Research Notebook for data collection and retention [HTML]
